The main objective of this study is to evaluate the efficacy of an eHealth cognitive behavioural intervention to treat insomnia in people with acquired brain injury.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the change in insomnia severity.
Secondary outcome
Secondary outcome measures are the change in fatigue, emotional well-being,
subjective cognitive functioning and participation.
Background summary
Internet delivered cognitive behavioural therapy is effective in improving
sleep in the general population. Since cognitive behavioural therapy is also
effective for sleep disorders after acquired brain injury, eHealth seems to be
a suitable intervention for this group as well. As far as we know, no study has
been performed on the efficacy of internet delivered cognitive behavioural
therapy for insomnia after brain injury.
Study objective
The main objective of this study is to evaluate the efficacy of an eHealth
cognitive behavioural intervention to treat insomnia in people with acquired
brain injury.
Study design
A multicenter single blind Randomized Controlled Trial (RCT) will be used, in
which the treatment group will receive the eHealth CBT treatment for insomnia
and the control group will receive treatment as usual, not specifically aimed
at insomnia.
Intervention
The eHealth intervention (CBT) for sleep complaints after acquired brain injury
consists of 6 eHealth sessions combined with 2 face-to-face sessions given on a
weekly basis to the treatment group. The total duration of the treatment is 6
weeks.
Study burden and risks
Measurements and treatment in this study do not have adverse consequences for
those involved, and there are no risks or burden associated with participation.
The mental burden will be minimal; participants have to fill in questionnaires
at 3 occasions in a 3-months period. The treatment group additionally has to do
daily registrations in a sleep diary-app for 8 weeks. The treatment group will
be counseled by the psychologist involved. The control group will receive
*treatment as usual*, after study completion they will be offered the same
eHealth intervention.
Relweg 51
Wijk aan Zee 1949EC
NL
Relweg 51
Wijk aan Zee 1949EC
NL
Listed location countries
Age
Inclusion criteria
-Acquired Brain Injury diagnosis (Traumatic Brain Injury, Stroke, Brain Tumor)
- Insomnia according to DSM-5 criteria
- Insomnia Severity Index > 10
- 18 years or older
Exclusion criteria
- Untreated sleep-apnea
- Current treatment or expected treatment during the study with main focus on fatigue or sleep (such as the CBT group therapy: *omgaan met beperkte belastbaarheid*).
- Major untreated or unstable medical or psychiatric comorbid condition (eg, epilepsy, psychosis)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63014.018.17 |
| OMON | NL-OMON20225 |